Feasibility and Therapeutic Efficacy of Ductoscopic Papilloma Extraction in Patients With Pathologic Nipple Discharge
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2018 |
| Start Date: | September 2013 |
| End Date: | March 2020 |
| Contact: | Sheldon Feldman, MD |
| Email: | sf2388@columbia.edu |
| Phone: | 212-305-9676 |
In this prospective clinical trial, patients who sign an approved informed consent for
ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the
study. Consented patients who have been diagnosed with a solitary papilloma within the
discharging duct will be recruited to have interventional ductoscopy.
Patients who are identified ductoscopically with a solitary non-sessile papilloma will
undergo an attempted ductoscopic papillomectomy (DP). Patients with ductoscopic findings
other than single non-sessile papilloma will undergo standard ductoscopically guided
microductectomy. The investigators will investigate whether the ductoscopic basket can be
used as a safe endoscopic extraction instrument without adverse events. Histopathological
evaluation will be performed to confirm the ductoscopic diagnosis and to determine the
existence of any malignant tissue.
ductoscopy to assess etiology of Pathologic nipple discharge (PND) will be enrolled in the
study. Consented patients who have been diagnosed with a solitary papilloma within the
discharging duct will be recruited to have interventional ductoscopy.
Patients who are identified ductoscopically with a solitary non-sessile papilloma will
undergo an attempted ductoscopic papillomectomy (DP). Patients with ductoscopic findings
other than single non-sessile papilloma will undergo standard ductoscopically guided
microductectomy. The investigators will investigate whether the ductoscopic basket can be
used as a safe endoscopic extraction instrument without adverse events. Histopathological
evaluation will be performed to confirm the ductoscopic diagnosis and to determine the
existence of any malignant tissue.
Nipple discharge is the third most common breast related symptom for which women seek medical
care, accounting for 37% of all breast complaints. Pathologic nipple discharge (PND) is
defined as spontaneous or easily expressible single duct nipple discharge, which contributes
to 5% of referrals to breast surgeons. Patients with PND represent a diagnostic and
therapeutic challenge for the surgical clinician. The most frequent causes of PND in these
cases are intraductal papilloma (IP) in 36% to 66%, ductal carcinoma in situ (DCIS) in 3% to
20% and other benign causes in up to 23%. The evaluation of women with PND usually involves
radiological(mammography, ultrasound, ducto (galacto)graphy and cytological (nipple smear,
ductal lavage) examinations; however, each of these procedures has found to have low
sensitivity and specificity. A ductoscope is an instrument which allows visualization of
abnormalities and polypoid lesions within the ductal system with access via the nipple
orifice to aid in evaluation of PND. Moreover, it is currently being used to improve
localization of lesions in patients with PND. Ductoscopically guided excision is an
improvement over standard surgical approaches with terminal duct excision which removes a
large volume of tissue with potential cosmetic deformity and for young women may make breast
feeding not possible. Ductoscopy also allows retrieval of intraductal cells for diagnostic
purposes using brush cytology.
care, accounting for 37% of all breast complaints. Pathologic nipple discharge (PND) is
defined as spontaneous or easily expressible single duct nipple discharge, which contributes
to 5% of referrals to breast surgeons. Patients with PND represent a diagnostic and
therapeutic challenge for the surgical clinician. The most frequent causes of PND in these
cases are intraductal papilloma (IP) in 36% to 66%, ductal carcinoma in situ (DCIS) in 3% to
20% and other benign causes in up to 23%. The evaluation of women with PND usually involves
radiological(mammography, ultrasound, ducto (galacto)graphy and cytological (nipple smear,
ductal lavage) examinations; however, each of these procedures has found to have low
sensitivity and specificity. A ductoscope is an instrument which allows visualization of
abnormalities and polypoid lesions within the ductal system with access via the nipple
orifice to aid in evaluation of PND. Moreover, it is currently being used to improve
localization of lesions in patients with PND. Ductoscopically guided excision is an
improvement over standard surgical approaches with terminal duct excision which removes a
large volume of tissue with potential cosmetic deformity and for young women may make breast
feeding not possible. Ductoscopy also allows retrieval of intraductal cells for diagnostic
purposes using brush cytology.
Inclusion Criteria:
- Be female
- Have pathologic (unilateral/uniductal) nipple discharge
- Been diagnosed with single papilloma
- Be over 18 years of age
- Sign the informed consent form
Exclusion Criteria:
- Have bilateral nipple discharge
- Personal history of breast cancer, ductal carcinoma in situ (DCIS) or lobular
carcinoma in situ (LCIS)
- Have BRCA 1 or 2 mutation
- Be currently pregnant or pregnant within the last 12 months
- Be currently lactating or lactated within the last 12 months
- Have received chemotherapy in the last 12 months
- Have had a Breast Imaging-Reporting and Data System (BIRADS) 3, 4, 5 or 6 mammograms
within the last year
- Have diagnosed with multiple or sessile papilloma by ultrasound, mammography and/or
ductoscopy.
- Have suspicious of malignancy in ultrasound
- Have an abnormal finding on the pre-operative nipple smear
- Have Gail Score >1.67
- Have had any subareolar or other surgery
- Have active infections or inflammation in a breast to be studied
- Have a known allergy to lidocaine
- Have abnormal liver function test
- Have medications know to be associated with breast discharge.
- Be unable to attend postoperative visits and imaging work-up.
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Sheldon M Feldman, MD
Phone: 212-305-9676
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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